Hello Ken: I live in a small town and have a love-hate relationship with Wal-Mart. I will try a different comparison. I would like my physician to be able to be a like the Food Network's Alton Brown. For those who are not familiar with Mr. Brown, he believes that every device in his kitchen should be able to perform multiple tasks. He will do things like cut cakes with saw blades, or turn a military surplus footlocker into a meat smoker. Now the people at the hardware store and the cooking supply store have products to sell. Some of the people at the store will try to sell things that we do not need or could be harmful if misused. I am willing to let Alton talk with the people at the store about alternative uses for their products. Alton and I may then consider how best to prepare dinner. If there is fraud involved, I want the people engaging in it prosecuted.
I do understand that the FDA will not be coming in their black helicopters to keep Alton from giving me a saw for cutting cakes. I do not want the black helicopters showing up at the hardware store on the assumption that any non-traditional use of saws should not be discussed between sales people and cooks. Joe Joseph J. Horton, Ph. D. Box 3077 Grove City College Grove City, PA 16127 724-458-2004 [email protected] In God we trust, all others must bring data. ________________________________________ From: Ken Steele [[email protected]] Sent: Tuesday, January 08, 2013 5:52 PM To: Teaching in the Psychological Sciences (TIPS) Subject: Re: [tips] Failure of Critical Thinking: When Advertising Trumps "Truth" Hi Joe: One difficulty I have with evaluating your argument is that I don't know the specific details of your case. This is not a call to reveal private details but it is difficult for me to plumb your benefit/danger ratios without details. I think Mike P's point is that dealing with Big Pharma is like dealing with Walmart, an aggressive and well-financed organization with a clear goal. Your point is that the entire world is not all like Walmart, or that there are good deals to be had at Walmart if you are a smart shopper. Both seem plausible positions, but are we talking about canoes or cannolis? Ken PS - Sorry to all who must live with a Walmart analogy; it is my world and there is not a fresh cannoli to be purchased in Boone. --------------------------------------------------------------- Kenneth M. Steele, Ph.D. [email protected] Professor Department of Psychology http://www.psych.appstate.edu Appalachian State University Boone, NC 28608 USA --------------------------------------------------------------- On 1/8/2013 4:47 PM, Horton, Joseph J. wrote: > Mike my point is that there is potential harm when the FDA > limits available treatments. Unless there is fraud involved, I > am all for open communication between pharmaceutical > companies, physicians and their patients. > > I certainly appreciate the role of well-done clinical trials. > (Note my signature file.) In the case of the drug I take, the > patent protection expired decades ago. No clinical trials will > be done. The potential side effects are well known. I am > probably in more danger from taking low dose aspirin daily. I > have to make decisions with less than perfect information > every day. I support letting information freely flow so people > can evaluate the evidence and make the most informed decisions > possible. > > Have a lovely evening, Joe > > Joseph J. Horton, Ph. D. Box 3077 Grove City College Grove > City, PA 16127 > > 724-458-2004 [email protected] > > In God we trust. All others must bring data. > > -----Original Message----- From: Mike Palij > [mailto:[email protected]] Sent: Tuesday, January 08, 2013 1:33 PM > To: Teaching in the Psychological Sciences (TIPS) Cc: Michael > Palij Subject: RE: [tips] Failure of Critical Thinking: When > Advertising Trumps "Truth" > > On Tue, 08 Jan 2013 08:59:25 -0800, Joseph J. Horton wrote: >> I am not particularly disturbed by this ruling depending >> upon just what claims are being made. If it is clear the >> claim is based on a collection of anecdotes rather than >> empirical study informing physicians that others have found >> a drug useful seems fine. > > I suggest reading the following blog entry from a legal firm > that maintains the blog as a source of information on legal > issues involving the FDA: > http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/12/a-deep-dive-into-the-second-circuits-caronia-decision-potential-next-steps-and-potential-enforcement.html > > >> I say this as one who regularly takes a drug for off label >> use. > > I am not sure how this is relevant since mere personal > experiences do not constitute data, only anecdote (at best a > case study if done systematically but case studies are not > scientific studies). That being said, I too have had > conditions where there was no established treatment and have > received numerous drugs off-label, none of which worked (you > don't know how much I hoped for a good placebo effect). A > major problem with off-label drug treatment are the > side-effects which can be significant. Sometimes one thinks > one is taking a step forward but winds up taking two steps > back. > >> It is a generic drug and has been for a very long time. Thus >> it costs very little. No one would invest the time and money >> to conduct a clinical trial for my issue. Yet the drug has >> dramatically improved my quality of life. Were the FDA to >> take away my physician's ability to prescribe it for me, I >> would be quite disappointed. > > With all sincerity, I am glad that the drug has done you good > but I hope you realize that if it is being used off-label: (a) > there is no empirical research evidence that the drug is the > cause of the improvement (that is one of the major problems > with using a drug in an off-label manner though there may be > various crappy "open label" studies -- studies where > participants and researchers know who is receiving the drug, > possibly with no placebo control) and (b) even if the "Caronia > case" goes in favor of the FDA on appeal, your doctor can > still treat you with the off label drug because the FDA's > focus is on the marketing of the drug. > > Below I quote from the legal blog I cite above but I give > warning that the quote is long. It does, however, provide > much significant context: > > NOTE: the FDA prosecutes off label marketing as a violation > of interstate commerce law; see the blog for details |On > November 30, 2009, a jury found Alfred Caronia guilty of > misdemeanor |conspiracy to introduce misbranded drugs into > interstate commerce. His |conviction was based on off-label > statements he made while employed |as a pharmaceutical sales > representative for Orphan Medical, Inc. ("Orphan"). > |Specifically, Caronia verbally promoted the drug Xyrem, a > central nervous |system depressant approved only for the > treatment of certain categories |of narcolepsy patients, to > treat a variety of other conditions including insomnia, > |fibromyalgia, and Parkinson's. He also promoted Xyrem for > use in an |unapproved patient population - individuals under > the age of 16. | |The government began its investigation of > Orphan in 2005, when former |Orphan saleswoman Shelley > Lauterbach filed a qui tam suit against the |company. During > the course of the investigation, Caronia was recorded |on two > occasions discussing off-label uses of Xyrem. On both > occasions, |Caronia was recorded speaking alongside Dr. Peter > Gleason, a doctor |that Caronia had engaged to participate in > "speaker programs" intended |to educate other physicians about > Xyrem. Caronia and Dr. Gleason |discussed off-label uses for > Xyrem with Dr. Jeffrey Charo, an undercover |informant for the > government. In 2006, the government filed charges against > |Orphan, Dr. Gleason, Caronia, as well as David Tucker (a > former Orphan |sales manager) for conspiring to promote Xyrem > for off-label uses, and |thereby introduce a misbranded drug > into interstate commerce. | |In March 2007, David Tucker > pleaded guilty to a single felony misbranding |charge. In > July 2007, Orphan pleaded guilty to felony charges, and its > |parent company, Jazz Pharmaceuticals, Inc., agreed to pay $20 > million and |enter into a Corporate Integrity Agreement to > resolve both criminal and civil |charges. In August 2008, Dr. > Gleason also pleaded guilty to criminal misbranding |charges. > | |Caronia, however, did not plead guilty and filed a motion > to dismiss his case |based inter alia on First Amendment > grounds. The District Court denied his |motion, but noted > that the allegations against Caronia included First > |Amendment-protected speech. Nevertheless, the District Court > concluded |that the government's interpretation of the FDCA > was constitutional under the |commercial speech doctrine > because it did not limit speech more than was |necessary to > achieve the government' objectives. On appeal of Caronia's > |criminal conviction, the Second Circuit disagreed. > > It is the Second Circuit's judgment that served as the basis > for the Nature Med article. The blog entry goes into what > possible follow-up actions that the FDA may engage in. > > -Mike Palij New York University [email protected] > --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13276.cca437dfff11995edc035566eabec9a7&n=T&l=tips&o=22775 or send a blank email to leave-22775-13276.cca437dfff11995edc035566eabec...@fsulist.frostburg.edu --- You are currently subscribed to tips as: [email protected]. 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